Status:
TERMINATED
SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
Lead Sponsor:
GE Healthcare
Conditions:
Blood Pressure (Low, Normal, High)
Eligibility:
All Genders
Phase:
NA
Brief Summary
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
Eligibility Criteria
Inclusion
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Ability of a minor subject ages 7 to 18 to provide written assent
- Ability to have multiple noninvasive blood pressures taken at one sitting
- Ability to apply three lead ECG, if needed for investigation
- Ability to detect the natural presence of an irregular pulse, for irregular pulse studies
Exclusion
- Any subject who cannot tolerate multiple blood pressure measurements
- Any subject who cannot undergo 3-lead ECG, if needed
- Any subject deemed unstable by the principal investigator
- Any subject for whom precautions are necessary because of communicable disease
- Any subject that has a known disease or condition compromises musculoskeletal integrity
- Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01482325
Start Date
November 1 2011
End Date
December 1 2013
Last Update
September 30 2016
Active Locations (2)
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1
St. Josephs Hospital
Milwaukee, Wisconsin, United States, 53210
2
Wisconsin Heart Hospital
Wauwatosa, Wisconsin, United States, 53226